Term
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Definition
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Term
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Definition
Food, Drug and Cosmetics Act
-NDAs
-Scientific proof of safety |
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Term
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Definition
Kefauver-Harris Act
-thialidomide
- required safety and efficacy
- IND |
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Term
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Definition
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Term
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Definition
Waxman-Hatch Act
-Drug pricing and compeition
-ANDA
-extended market exclusivity |
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Term
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Definition
| International Conference on Harmonization |
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Term
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Definition
| Prescription Drug User Fee Act (PDUFA) |
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Term
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Definition
| Expedited Drug Development |
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Term
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Definition
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Term
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Definition
FDA Modernization Act
-reduced NDA review times
-renewed PDUFA |
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Term
|
Definition
Food and Drug Amendments Act (FDAA)
-renewed PDUFA
-restrictions on DTC advertising |
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